The Alliance for Hippocratic Medicine wants Judge Kacsmaryk to overturn the FDA’s medical approval for mifepristone, which might effectively ban the abortion pill across the United States.
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A Texas judge is about to deliver a key ruling in a closely watched case difficult the Food and Drug Administration’s approval of the mifepristone abortion pill.
The lawsuit filed by a group of doctors who oppose abortion, called the Alliance for Hippocratic Medicine, is unprecedented, and Judge Matthew Kacsmaryk of the Northern District of Texas in the US could rule in many alternative ways.
He could order the FDA to completely withdraw mifepristone from the US market. It is also possible that Kacsmaryk could order the agency to impose stricter restrictions on access to mifepristone, but refrain from stopping sales altogether. A judge could also rule in favor of the FDA, but anti-abortion groups would appeal.
Kacsmaryk told defense attorneys involved in the case during oral arguments in Amarillo on Wednesday that he would issue a decision “as soon as possible.”
Abortion rights groups and legal experts expect the judge to rule against the FDA in some form. Kacsmaryk joined the court in 2019 after being appointed by former President Donald Trump. His nomination was unanimously opposed by Senate Democrats in addition to Republican Susan Collins of Maine over concerns about his views on abortion and LGBTQ rights.
Wendy Davis, senior counsel at Planned Parenthood Texas Votes, told reporters at a Wednesday news conference that abortion rights activists are preparing for the worst.
A court order blocking the sale of mifepristone would have the best impact in states where abortion stays legal, said Carrie Flaxman, who leads litigation at the Planned Parenthood Federation of America.
Rachel Rebouche, an authority in reproductive health law at Temple University, said an order to block the sale would cause confusion as there might be further litigation over whether such an order is legal.
Possible warrant
If Kacsmaryk issues an order to withdraw mifepristone from the market, there are several options for preparing such an order. The impact of its decision will depend on the language of the order and the way the FDA decides to respond.
“There are lots of ways a court can resolve in our favor,” said Erik Baptist, who represents the Alliance for Hippocratic Medicine on the case and is a senior counsel at Alliance Defending Freedom, one other anti-abortion group.
Baptist told reporters at a press conference on Thursday that a judge could immediately overturn the FDA’s approval or could order the agency to begin the means of withdrawing mifepristone from the US market.
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“But how the court works by way of time – whether it goes into effect immediately or goes into effect in 30 days, again is at the discretion of the court,” Baptist said.
Rebouche said it’s possible the judge will issue an order that directs the FDA to begin the means of recalling mifepristone while suspending the drug from the market as the agency conducts the process.
Quick call
If Kacsmaryk orders the immediate withdrawal of mifepristone, the Biden administration will ask him to hold off the decision pending appeal, said Glenn Cohen, an authority in health law at Harvard. If Kacsmaryk refuses, the administration will refer the case to the US Fifth Circuit Court of Appeals.
“My guess is that the residence permits are already drawn up. Someone will take them to court inside hours of the decision,” said Cohen, who previously worked as a lawyer in the Department of Justice’s civil division.
Cohen, Rebouche and 17 other drug law experts, in a filing filed in court in support of the FDA, told Kacsmaryk that ordering the immediate recall of mifepristone can be against federal law.
They said the power to recall a drug rests with the FDA commissioner, who makes that call based on scientific evidence about the drug’s safety and effectiveness. The manufacturer, on this case Danco Laboratories, is also to be heard during the trial.
“The FDA would argue that the court cannot withdraw the drug – the FDA must withdraw the drug, and federal statute prevents the court from withdrawing the drug,” Rebouche said.
The FDA may drag out this process
If Kacsmaryk decides not to immediately recall mifepristone and as an alternative directs the FDA to initiate a formal process to recall the drug from the market, the agency can use the process to block it, assuming it doesn’t suspend approval in the meantime.
“With the FDA following these procedures, it takes months, if not years, to withdraw a drug from the market, so the FDA could try to pull the process out a bit longer to keep the drug on the market in the meantime,” said Allison Whelan, an FDA law expert at Georgia State. university.
“The FDA doesn’t like having its science and legitimacy questioned,” said Whelan, who also signed a court filing in support of the FDA.
Mifepristone off the label
The agency also has enforcement discretion where it will possibly select not to prosecute corporations selling unapproved drugs, Whelan said. Mifepristone is also approved to treat a condition called Cushing’s syndrome. She said some clinics may select to prescribe the pill off-label for abortion.
And mifepristone is utilized in a two-drug regimen with one other drug called misoprostol. Alliance Defending Freedom’s Baptist told reporters at a press conference on Thursday that the lawsuit only concerns the approval of mifepristone.
Misoprostol is really useful as a standalone approach to abortion by the World Health Organization. Although the FDA has not approved misoprostol alone as an abortion drug, clinics plan to use the pill as a substitute to mifepristone.
The American College of Obstetricians and Gynecologists recommends misoprostol as a substitute to early abortions if mifepristone is not available, even though it is not as effective as the two-drug regimen, by organization.
Tighter restrictions
Kacsmaryk could also refrain from halting the sale of mifepristone and as an alternative order the FDA to impose stricter restrictions on the drug’s distribution.
In January, the FDA permanently lifted the requirement for patients to receive mifepristone in person from a certified healthcare skilled. This allowed telehealth appointments to be made and mifepristone to be delivered by mail.
The Alliance for Hippocratic Medicine asked the judge to reimpose FDA restrictions that had been revoked over the years, arguing that an 1873 federal act, called the Comstock Act, prohibited the mailing of abortion drugs.
Rebouche said the Comstock Act hasn’t been enforced in many years, but there’s a possibility the judge could try to revive the statue to force the FDA to reimpose the requirement for patients to receive mifepristone in person.